510(k) K211648

Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay by Diazyme Laboratories, Inc. — Product Code DFH

K211648 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories, Inc. for the device "Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay". The FDA issued a decision of Substantially Equivalent on September 8, 2022. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Diazyme Laboratories, Inc. has at least 10 other 510(k) clearances on record.